Alaris PCA Module 8120 — Class I medical device recall Z-0186-2024
Ongoing recall by CareFusion 303, Inc., reported 2023-11-15, distributed nationwide. Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syri
| Recall number | Z-0186-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 303, Inc., San Diego, CA, United States |
| Recall initiated | 2023-09-15 |
| Classified | 2023-11-06 |
| Reported by FDA | 2023-11-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, BH, CA, CH, DE, IL, IN, IT, JP, KR, KW, MX, MY, NL, NZ, PH, PK, QA, SG, TR, TW, ZA |
| Quantity | 86,393 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10885403515224, 10885403515231, 10885403515248, 10885403516023, 10885403801518, 10885403801532, 10885403801549 |
Product
Alaris PCA Module 8120
Reason for recall
Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0186-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.